Valvular heart disease has a mortality rate of approximately 40% in the United States alone. The major reason for this high mortality is the lack of a suitable replacement for diseased valves. Current replacement valves lack either the structural, functional (mechanical), or both structural and functional characteristics of the native valves they are intended to replace. These deficiencies result in the manifestation of a variety of valve rejection and failure problems.
The engineering of substitute heart valves using biodegradable scaffolds and autologous cells has undergone considerable advances in recent years. Research conducted attempting to optimize cell source and culturing techniques for developing functional tissues has had promising results. However, in vivo studies resulted in valves that did not perform as well as the native valves they were intended to replace. Accordingly, there continues to be a need for artificial implantable medical devices, such as heart valves.